Dear all:

I agree with Christina that you cannot conclude that there isn't harm if no one has studied it.  And it is in the arena of "harm" that we should be especially cautious, particularly with something that we are already having challenges with, which is preterm labor.  Labor is already hurried along because mothers want to be induced early and we of all professions should know that there are definitely negative ramifications for how infants feed.  I disagree with her that "evidence-based medicine" consists of looking only at the existing evidence.  Part of evidence based is going the extra mile to challenge the assumptions enough to find holes in the evidence and fill them with solid research.

The problem with studying risk is that if you have a small sample size, and that condition is serious but less frequent, then you won't pick it up.  This is why there should be sources of funding to conduct research without conflicts of interest to check medications, supplements, etc --- because those that are already convinced these work well are not necessarily those who are going to challenge their own assumptions enough to design studies in ways that really do capture the risks.

Obstetrics has a history of stopping at the Apgar score and investigating no further (there was a nice article a few years back -- in New York Magazine that really illustrated this for me -- before they used the Apgar score they were not resuscitating babies that could easily be saved).  This means that we have very little solidly designed evidence on the long term impact of many of those early practices.  Similarly, since breastfeeding was demeaned to the point that for many generations it was simply something you could fix with a can of formula --- so while there is data, there is not as much as needed to really understand how other health problems influence breastfeeding.

An example of the dual problem occurs in the recent American Academy of Pediatrics policy statement on iron deficiency.  Their basis for recommending iron supplementation appears to have been made on the basis of one study.  The study had a huge drop out rate of about 50%.  The final sample size was as low as 13 subjects in some categories of measurement.  The final sample size was small.  They claimed there was no harm from iron supplementation begun at one month of age based on just "oxidant status" -- they did not observe or collect information on any other potential risks.  I've dug through three studies to find the methods section for their "dietary assessment" and it is still as vague as "a three day record".  They never say a record of what.  I did find out that they were not studying exclusively breastfed infants -- the infants were considered "exclusive" if they had one bottle of formula a day or less.  We all know the implications of "a bottle of formula or less" for HIV transmission --- deadly.

Here's what they did not seem to measure in that study:
* early episodes of aspiration from trying to squirt a sugary liquid into the infants mouth (in both the treatment and the control group)
* oral defensiveness from this early intrusion
* potential increases in infections due to changing the iron absorption of the gut at one month of age
* decreased frequency of breastfeeding
* earlier introduction of solid foods

Furthermore, even with randomization one should check on confounding factors --- those factors which may influence the outcome and make it seem like the intervention was responsible for the effect, when in fact it was due to the confounding factor that was more common in the intervention group. 
They did not confirm that randomization of the treatments led to equal distribution among the treatment groups for:
* gestational age at birth
* time to cord clamping
* frequency of breastfeeding
* use of other supplements
* time of introduction of solids
* type of solids

I could go on.  The AUTHORS themselves said that more studies needed to be done.  Nevertheless, in my initial read, it appears that the AAP may have made a policy statement to start iron supplementation at four months of age on the basis of a study that included at most 42 infants as low as 14 infants in some groups with a huge drop out rate and minimal efforts to look at risk factors.  The study in fact did NOT compare supplementation between EXCLUSIVELY bresatfed infants who were started on iron supplements at four months of age, it compared supplementation among "predominantely" breastfed infants who were started on iron supplements at one month of age.  Since the "control group" was not exclusively breastfed, we have no idea what those other substances (e.g. formula or cow's milk or watered down cereal or who know's what" may have done to the lining of the gut and the absorption of iron.

This is NOT evidence based policy as far as I'm concerned.  I'm going to read this study and look at the details more carefully, but so far, they have not demonstrated to me that they have done due diligence to "do no harm" with their blanket recommendation on such flimsy evidence.

Best regards, 

Susan E. Burger, MHS, PhD, IBCLC

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